PRO CTCAEs The 2017 update PROs: context Usual description of - - PowerPoint PPT Presentation

PRO CTCAEs

The 2017 update

PROs: context

• Usual description of adverse events with the 790-items

CTCAE (Common Terminology of Adverse Events) criteria under-detects symptomatic, though significant events

• Patients’ reports better reflect their underlying health

status than doctors do w/CTCAE, and most of patients are capable and willing to report their symptoms

• Direct patients’ reporting bypasses the multistep process

to research database where information is lost

PROs: context

• PRO-based AE reporting must comply with several rules:
• AEs must include « classic » and non-classic items

(unanticipated symptoms)

• Reporting must catch the worst magnitude of any AE
• AEs must be assessed at sufficiently frequent intervals
• AEs to be scored independently

NCI developed PRO-CTCAE

• A consortium was established
• Built a library (where you pick the items of your choice)
• Terms adapted to non-medical users
• PRO-CTCAE responses are scored from 0 to 4
• Up to three questions per AE Item (Frequency, Severity,

Interference)

Where were we last year with PRO-CTCAE ?

• Paper = IVRS = iPad
• Validated in foreign languages: English, Spanish
• On the way: German, Swedish, Danish, Chinese,

Japanese, Korean, Italian

• Desperately missing: many

including French (GINECO willing to help)

Where are we now with PRO- CTCAE ?

Though, GINECO will still not FREXIT

• Done: English, Danish, German, Japanese, and Spanish
• In development: Chinese, Czech, Dutch-Flemish, French,

Greek, Hungarian, Italian, Korean, Polish, Portuguese, Russian, and Swedish)

• Will be posted upon completion, but no ETA
• GINECO offered to help to speed this a little bit. Didn’t work

Can we anticipate ?

• Incorporate PRO CTC AE ’s in the next GCIG studies
• Mandatory because
• OS is increasing
• Innovative, maintenance therapies are underway
• QoL to be a major endpoint
• Has to be appropriately monitored

United we stand